Apparatus for Measuring Distal Forces on a Working Instrument

ABSTRACT

A robotic catheter manipulator includes a guide catheter including proximal and distal ends and lumen extending there through. A flexible bellows is secured at one end to the proximal end of the guide catheter and at the other end to a seal configured to receive a working catheter. In a loaded state, the working catheter is fixed relative to the seal. A ditherer is operatively connected to the seal for dithering the working catheter relative to the guide catheter when placed therein. The robotic catheter manipulator includes at least one force sensor for measuring the force applied to the working catheter by the ditherer. Force measurements may be translated into an estimated force that is experienced at the distal end of the working catheter which may then be displayed to the physician via a monitor or display.

REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 11/678,001, filed Feb. 22, 2007, which claims the benefit under 35U.S.C. §119 to U.S. Provisional Patent Application Ser. Nos. 60/776,065,filed on Feb. 22, 2006, and 60/801,355, filed on May 17, 2006. Theforegoing applications are all incorporated by reference into thepresent application in their entirety for all purposes.

FIELD OF THE INVENTION

The invention relates generally to minimally-invasive instruments andsystems, such as manually or robotically steerable catheter systems, andmore particularly to steerable catheter systems for performing minimallyinvasive diagnostic and therapeutic procedures. More particularly, theinvention pertains to devices and methods that are capable of measuringor sensing forces experienced by a medical instrument when in contactwith surrounding objects such as tissue structures.

BACKGROUND

Currently known minimally invasive procedures for the treatment ofcardiac and other disease conditions use manually or roboticallyactuated instruments which may be inserted transcutaneously into bodyspaces such as the thorax or peritoneum, transcutaneously orpercutaneously into lumens such as the blood vessels, through naturalorifices and/or lumens such as the mouth and/or upper gastrointestinaltract, etc. For example, many conventional minimally-invasive cardiacdiagnostic and/or interventional techniques involve accessing the rightatrium of the heart percutaneously with a catheter or catheter system byway of the inferior vena cava. When controlling an elongate instrument,such as a catheter, in any one of these applications, the physicianoperator can push on the proximal end of the catheter and attempt tofeel the distal end make contact with pertinent tissue structures, suchas the walls of the heart. Some experienced physicians attempt todetermine or gauge the approximate force being applied to the distal endof a catheter due to contact with tissue structures or other objects,such as other instruments, prostheses, or the like, by interpreting theloads they tactically sense at the proximal end of the inserted catheterwith their fingers and/or hands. Such an estimation of the force,however, is quite challenging and somewhat imprecise given the generallycompliant nature of many minimally-invasive instruments, associatedfrictional loads, dynamic positioning of the instrument versus nearbytissue structures, and other factors.

Manually and robotically-navigated interventional systems and devices,such as steerable catheters, are well suited for performing a variety ofminimally invasive procedures. Manually-navigated catheters generallyhave one or more handles extending from their proximal end with whichthe operator may steer the pertinent instrument. Robotically-navigatedcatheters may have a proximal interface configured to interface with acatheter driver comprising, for example, one or more motors configuredto induce navigation of the elongate portion of the instrument inresponse to computer-based automation commands, commands input by theoperator at a master input device, combinations thereof, or the like.Regardless of the manual or electromechanical nature of the drivingmechanism for a diagnostic or interventional instrument, the operatorperforming the procedure would prefer to have accurate, timelyinformation regarding the forces experienced at the distal portion ofthe working instrument. There thus is a need for an improvedforce-sensing technology to facilitate the execution ofminimally-invasive interventional procedures. It is desirable to havethe capability to accurately monitor the loads applied by or to thesubject medical instrument or device from adjacent tissues and otherobjects.

SUMMARY

In one embodiment of the invention, a robotic catheter manipulatorincludes a robotically operated guide catheter including proximal anddistal ends and lumen extending there through. A flexible bellows issecured at one end to the proximal end of the guide catheter and at theother end to a seal configured to receive a working catheter. Forexample, the seal may include a Touhy seal. A ditherer is operativelyconnected to the seal for dithering the working catheter relative to theguide catheter when placed therein. The robotic catheter manipulatorincludes at least one force sensor for measuring the force applied tothe working catheter by the ditherer.

In another embodiment, the ditherer includes a reciprocating dithercarriage containing a pivotable load bearing member that can swingback-and-forth as the dither carriage is dithered. Opposing load cellsare positioned on either side of the pivotable load bearing member witheach load cell containing a force sensor that measures compressionforces when in contact with the pivotable load bearing member. Thepivotable load bearing member may be mounted to the working cathetereither directly or through a seal such as the Touhy seal. Forcemeasurements throughout one or more dither cycles are then subject todata processing which determines the estimated force at the distal endof the working catheter. The data processing may include a comparison ofthe waveform or force profile taken during an insertion/withdrawal cyclewhen the distal end is subject to a force and the waveform or forceprofile of a baseline measurement obtained when the distal end is notsubject to any external force.

In still another embodiment, an apparatus for sensing the forces appliedto the distal end of a robotically controlled working catheter includesa robotically controlled guide catheter that is configured for insertioninto a body lumen of a patient. The body lumen may include, for example,a blood vessel or a chamber within the heart. The guide catheterincludes a lumen extending from a proximal end to a distal enddimensioned to receive a working catheter. The working catheter includesa distal end that projects distally from the distal end of therobotically controlled guide catheter and a proximal end that extendsproximally from the robotically controlled guide catheter. A ditherer isoperatively connected to the proximal region of the working catheter fordithering the working catheter relative to the guide catheter. Theditherer may be directly coupled to the working catheter or indirectionthrough some other component such as, for example, a seal. The apparatusincludes at least one force sensor for measuring the force applied tothe working catheter by the ditherer.

In still another embodiment, a system for monitoring the estimated forceexperienced by a distal end of a working catheter includes a guidecatheter mounted to a robotic catheter manipulator, the guide catheterincluding a lumen therein adapted to receive the working catheter. Areciprocating ditherer is disposed on the robotic catheter manipulator,the reciprocating ditherer being operatively connected to a proximalregion of the working catheter so as to dither the working catheter withrespect to the guide catheter. First and second force sensors areprovided for measuring forces applied to the working catheter duringinsertion and withdrawal, respectively. The system includes a processoror multiple processors for calculating the estimated force on the distalend of the working catheter based at least in part on the measuredforces obtained by the first and second force sensors. For instance, theprocessor(s) may calculate average force values during the insertion andwithdrawal strokes when the distal end of the working catheter is incontact with a surface or object and compares this to average forcevalues obtained in a baseline measurement where the distal end of theworking catheter is free. The comparison may include, for example, asubtraction process to eliminate substantially all force componentsacting on the system except for the force at the distal end of theworking catheter.

Any number of types of working catheters may be used in connection withthe system. These include by way of illustration and not limitation,ablation catheters, dilating catheters, and electrophysiology catheters.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A schematically illustrates a system for measuring forces on adistal end of a working instrument that is manipulated by a roboticinstrument system.

FIG. 1B illustrates a ditherer coupled to a manually operated, steerableguide catheter and a working instrument.

FIG. 1C illustrates a ditherer coupled to a rigid member such as atrocar and a working instrument.

FIG. 1D illustrates a robotically manipulated rigid or semi-rigid toolthat includes a ditherer for reciprocating a working instrument thereinfor determining the force experienced at the distal end of the workinginstrument.

FIG. 1E illustrates a ditherer that is used to move a working instrumentback-and-forth within an outer flexible scope or elongate member.

FIG. 1F illustrates a ditherer that is used to move a working instrumentsuch as a guide wire that is disposed within an elongate imaging toolsuch as an endoscope.

FIG. 2 illustrates a cross-sectional view of the guide instrument,sheath, and working instrument taken along the line A-A′ of FIG. 1A.

FIG. 3 illustrates a physician or other using stationed at an operatorcontrol station that is operatively connected to a robotic instrumentsystem according to one aspect of the invention.

FIG. 4 illustrates a perspective view of an operator control station andassociated cart.

FIG. 5 illustrates a schematic representation of a method and system fordithering a working instrument relative to a guide instrument accordingto one embodiment of the invention.

FIG. 6 illustrates a schematic representation of a method and system fordithering a working instrument relative to a guide instrument accordingto another embodiment of the invention.

FIG. 7 illustrates a schematic representation of a method and system fordithering a working instrument relative to a guide instrument accordingto one embodiment of the invention.

FIG. 8 illustrates a schematic representation of a method and system fordithering a working instrument relative to a guide instrument accordingto one embodiment of the invention.

FIG. 9 illustrates a schematic representation of a method and system fordithering a working instrument relative to a guide instrument accordingto one embodiment of the invention.

FIG. 10 illustrates a schematic representation of a method and systemfor dithering a working instrument relative to a guide instrumentaccording to one embodiment of the invention.

FIG. 11 illustrates a drape being positioned over the robotic instrumentsystem.

FIG. 12 illustrates a schematic representation of a method and systemfor dithering a working instrument relative to a guide instrumentaccording to one embodiment of the invention. In this embodiment, thedithering motion is rotational as opposed to longitudinal.

FIG. 13 illustrates a perspective view of a robotic instrument systemwithout the working instrument.

FIG. 14 illustrates a perspective view of a distal end of the roboticinstrument system without the working instrument being attached. Alsoremoved are the guide instrument and the outer sheath.

FIG. 15 illustrates a working instrument being secured via two clamps toa seal. The seal interfaces with a flexible bellows that interfaces withthe guide splayer. Also illustrated is a source of fluid (e.g.,pressurized saline) that is used to flush the region between the guideinstrument and the working instrument.

FIG. 16 illustrates a perspective view of a robotic instrument systemwith the working instrument being loaded thereon.

FIG. 17 illustrates another perspective view of a robotic instrumentsystem with the working instrument being loaded thereon.

FIG. 18A illustrates a guard ring that is mounted around a load bearingmember of the ditherer.

FIG. 18B illustrates the load bearing member being mounted on a pivotpoint between opposing load cells each of which contain a force sensorfor measuring compressive forces.

FIG. 18C illustrates the structure of FIG. 18 with the guard ringmounted about the load bearing member.

FIG. 19 illustrates a perspective view of the dither carriage holdingthe opposing load cells. Also shown are the opposing force sensorsdisposed on the load cells.

FIG. 20 is a schematic representation of a working instrument beingoperatively coupled to the load bearing member of the ditherer. Alsoshown are the force sensors contained in the opposing load cells.

FIGS. 21A-21B illustrate the waveform or force profile obtained from theforce sensors during a single insertion and withdrawal cycle.

FIG. 22 illustrates a baseline waveform or force profile that isoverlaid with the waveform or force profile obtained when the distal endof the working instrument is subject to an external force. The dashedline represents the baseline (no force at distal end) while the solidline represents the measurements obtained in response to an appliedforce at the distal end of the working instrument.

FIG. 23 illustrates a perspective view of a chassis for the roboticinstrument system that holds the pivoting lever arm that moves thedither carriage back-and-forth in response to the cable-driven pulleys(cable not shown).

FIG. 24 illustrates an exploded view of the ditherer carriage and thelever arm components that is used to dither the dither carriageback-and-forth according to one aspect of the invention.

FIG. 25 illustrates a cable with crimp balls that is used to drive theditherer according to one embodiment.

FIG. 26 illustrates a top-down plan view of the lever arm and mechanicalditherer mounted on the dither carriage. The lever arm is shown at ornear the “six o-clock” position in which the mechanical ditherer is atthe end of withdrawal or the beginning of insertion into the guideinstrument.

FIG. 27 illustrates a top-down plan view of the lever arm and mechanicalditherer mounted on the dither carriage. The lever arm is shown at ornear the “twelve o-clock” position in which the mechanical ditherer isat the end of insertion or the beginning of withdrawal into the guideinstrument.

FIG. 28 is a perspective view of the motor-based drive system that usesa plurality of pulleys to pivot the lever arm back-and-forth to causereciprocating motion in the ditherer.

FIG. 29 is another perspective view of the drive system illustrated inFIG. 28.

FIG. 30A illustrates a Touhy seal having a working instrument disposedtherein.

FIG. 30B illustrates another view of a Touhy seal.

FIG. 30C illustrates a perspective view of a pivoting holder used aspart of a mechanical ditherer according to one embodiment.

FIG. 30D illustrates the Touhy being inserted into the pivoting holderof FIG. 30C.

FIG. 30E illustrates a perspective view of a cam having a groovetherein.

FIG. 30F illustrates the cam of FIG. 30E engaged with the pivotingholder of FIG. 30C.

FIG. 30G illustrates a dither support block that holds the cam andpivoting holder. Also shown is a working instrument passing through theTouhy seal.

FIG. 31 illustrates a top down plan view of the guide splayer along withthe mechanical ditherer embodiment illustrated in FIGS. 30A-30G. A drivecable is shown coupled to the cam. A flexible bellows is alsoillustrated that is connected to the Touhy seal.

FIG. 32A is an enlarged, top down plan view of the mechanical dithererillustrated in FIGS. 30A-30G and FIG. 31. A strain gauge is shown on thepivoting holder.

FIG. 32B is an enlarged, top down plan view of the mechanical dithererillustrated in FIGS. 30A-30G and FIG. 31. In this embodiment, twoopposing force sensors are affixed to the supports on either side of thepivoting member.

FIGS. 33A and 33B illustrate perspective views of a mechanical dithereraccording to another embodiment.

FIG. 33C illustrates a cam having a slot therein.

FIG. 33D illustrates a linkage having pins on opposing ends.

FIG. 33E illustrates the linkage of FIG. 33D in mating arrangement withthe cam of FIG. 33C.

FIG. 33F illustrates a pivot holder connected to the linkage of FIG.33E.

FIG. 33G illustrates a base used to hold the components of the dithererillustrated in FIGS. 33A and 33B.

FIGS. 34A-34D illustrate various embodiments in which the estimatedforce and estimated error are presented to a physician via a monitor,display or the like.

FIG. 35 illustrates a process flow diagram for operating a roboticinstrument system according to one embodiment.

FIG. 36 illustrates a process flow diagram for operating a roboticinstrument system according to another embodiment.

DETAILED DESCRIPTION

FIG. 1A illustrates a schematic, top-level view of a robotic instrumentsystem 2 according to one embodiment. FIGS. 1B-1F illustrate variousother embodiments of a system 2 that may utilize a mechanical ditherer50 or other dithering mechanism or device as described herein. Forexample, FIG. 1B illustrates a manually-operated, steerable guidecatheter 500 that is mounted via a base 24 containing a ditherer 50. Theditherer 50 is coupled to a working instrument 30 that is ditheredback-and-forth relative to the guide catheter 500. The workinginstrument 30 may include any number generally elongate members that aretypically used during medical diagnostic or therapeutic procedures. Forexample, the working instrument 30 may include by way of illustrationand not limitation, a catheter, guide wire, imaging element, laser fiberor bundle of fibers, tool, or other instrument.

FIG. 1C illustrates a ditherer 50 used in conjunction with a relativelyrigid elongate member such as, for example, a trocar 600. The ditherer50 is coupled to a working instrument 30 that is dithered in areciprocating fashion through a lumen (not shown) contained in thetrocar 600. As in the prior embodiment, a base 24 is used to secure theditherer 50 relative to the trocar 600.

FIG. 1D illustrates still another embodiment in which the ditherer 50 iscoupled to a working instrument 30 that is passed through a tool 700which may include a rigid or semi-rigid shaft having one or more lumenstherein adapted to receive a working instrument 30. The tool 700 may becoupled to a housing 702 that mechanically and electrically couples thetool 700 to a robotically-controlled manipulator. For example, the tool70 may be coupled to a robotically controlled instrument driver such as,for instance, the DA VINCI surgical system sold by Intuitive Surgical,Inc. of Sunnyvale, California.

FIG. 1E illustrates an embodiment in which a working instrument 30 suchas an endoscope is coupled to the ditherer 50. The working instrument 30can thus be moved relative to an outer flexible member such as asegmented, flexible scope 800 of the type developed by NeoGuide Systems,Inc. FIG. 1F illustrates still another embodiment in which, for example,the ditherer 50 is used in connection with visualization tool such as anendoscope 900. In this embodiment, the ditherer 30 is coupled to aworking instrument 30 such as a guide wire that is ditheredback-and-forth with respect to the endoscope 900. The endoscope 900 maybe rigid, flexible, or semi-rigid.

Referring back to FIG. 1A, the depicted robotic instrument system 2,variations of which are described in further detail, for example, inU.S. Utility patent application Ser. No. 11/640,099 filed on Dec. 14,2006, Ser No. 11/637,951 filed on Dec. 11, 2006, and Ser. No. 11/481,433filed on Jul. 3, 2006, which are incorporated by reference herein intheir entirety, comprises a robotically-steerable guide instrument 4 andan outer sheath instrument 6 which may also be robotically-steerable.For illustrative purposes, a system comprising both a flexible roboticguide instrument 4 and a flexible robotic sheath instrument 6, each ofwhich may also be termed a variation of a steerable “catheter”, asdescribed in the aforementioned applications which are incorporated byreference, is depicted, although variations comprising only a flexiblerobotic guide instrument 4 or only a flexible robotic sheath instrument6, as accompanied by a flexible working instrument 30 as describedbelow, may be desired. Further, the dithering-based force sensingtechnologies described herein may be utilized with non-steerable and/ornon-flexible or semi-flexible instrument set configurations (forexample, to sense forces at the distal end of a working instrumentadvanced through a straight or bent, rigid, flexible, or semi-flexiblesteerable or nonsteerable trocar, or other straight or bent, rigid,flexible, or semi-flexible, steerable or nonsteerable minimally invasiveinstrument defining a working lumen in which a working instrument may bemoved in an oscillatory fashion—such as the robotic instrumentsavailable from manufacturers such as NeoGuide Systems, Inc., StereotaxisInc., and Intuitive Surgical, Inc.). Furthermore, the dithering-basedforce sensing technologies described herein may be utilized in otherapplications with non-slender, or non-minimally-invasive, instruments,so long as such instruments define a lumen through which a workinginstrument may be moved in an oscillatory fashion and detected, asdescribed below.

In the depicted embodiment of FIG. 1A, robotic steering actuation isprovided to the sheath and guide instruments in the depicted embodimentby a robotic instrument driver 400. Both the guide instrument 4 andsheath instrument 6 define respective lumens 8, 10, and in the depictedconfiguration, the sheath instrument 6 coaxially surrounds a portion ofthe guide instrument 4. The robotically-steerable guide instrument 4 andsheath instrument 6 comprise a number of control members 12, as shown inthe cross-sectional view of FIG. 2, that may be used to steer the guideinstrument 4 and/or sheath instrument 4 using actuations from therobotic instrument driver 400.

The control members 12 may comprise wires or the like that areselectively tensioned via respective proximal instrument portions or“splayers” 14, 16 that are configured to be interfaced with the roboticinstrument driver 400 to provide steering actuation to the guideinstrument 4 and sheath instrument 6, along with insertion or retractionalong the longitudinal axis of the proximal lumen defined by the guideinstrument 4 or sheath instrument 6 via motors within the instrumentdriver 400 which are configured to insert and retract the splayers 14,16 independently relative to each other and relative to the outerstructure of the instrument driver 400 and/or relative to the operatingtable. For example, the guide splayer 14 and sheath splayer 16 maycomprise a plurality of motor-driven, rotating spools or drums (notshown) that can selectively tension or release the control members 12 ofthe pertinent instrument to provide controlled steering to the guideinstrument 4 and/or sheath instrument 6. As described above, thesplayers 14, 16 may also move longitudinally (“insertion” or“retraction”) with respect to the robotic instrument driver 400 mainstructure as illustrated with arrows “A” in FIG. 1A.

As seen in the embodiment depicted in FIG. 1A, the guide instrument 4passes through the lumen 10 of the sheath instrument 6 and is thusmoveable with respect thereto. As seen in the top detail of FIG. 1A, thedistal end 18 of the guide instrument 4 projects distally with respectto the distal end 20 of the sheath instrument 6. Of course, in otheraspects, the guide instrument 4 may be withdrawn proximally such thatthe distal end 18 is substantially flush with the distal end 20 of thesheath instrument 6, or withdrawn proximally even further such that thedistal end 18 is hidden within the distal end 20 of the sheathinstrument. The contact surfaces between the guide instrument 4 and theouter sheath instrument 6 may be coated with a lubricous coating suchas, for example, PTFE to reduced frictional forces there between.

Moreover, as explained in more detail below, an optional flushing fluidmay be pumped or forcibly moved between the guide instrument 4 and outersheath instrument 6. The flushing fluid may act as a lubricant inaddition to preventing retrograde flow of blood and other biologicalmaterial into the space between the guide instrument 4 and outer sheathinstrument 6.

Still referring to FIG. 1A, a working instrument 30 is shown beingsecured to the robotic instrument driver 400. The working instrument 30may comprise any number of types of instruments, including but notlimited to guidewires, probes, laser fibers, injection devices, surgicaltools, and catheters, such as electrophysiology catheters, ablationcatheters, and the like. FIG. 1A illustrates an ablation catheter as theworking instrument 30 with electrodes 32 positioned at a distal end 34of the ablation catheter. The working instrument 30, or “workingcatheter” in this instance, may be custom designed for use with therobotic instrument system 2 or, alternatively, the working instrument 30or working catheter may comprise an off-the-shelf catheter such as thoseused by physicians in conventional, manually-navigated procedures. Theworking instrument 30 is loaded into the robotic instrument system 2 bypassing the distal end 34 through a seal 40. The seal 40 may comprise a“Touhy” that has a small hole or opening through which the workinginstrument 30 passes. The Touhy seal 40 may have an elongate or rigidbody with a proximal end cap 44 (seen e.g., in FIGS. 13, 14, 16, and 17)or the like that is used to create a non-slip, fluid-tight seal betweenthe Touhy 40 and the working instrument 30.

As seen in FIG. 1A, the Touhy seal 40 is secured to a mechanical“ditherer” 50 via a clamp 54. The mechanical ditherer 50 is a mechanicalsubsystem that moves in a reciprocating or oscillating motion in thedirection of arrow B, and may be coupled to other structures, such as aworking instrument, to induce oscillatory, reciprocating, or “dithering”motion in such other structures. The mechanical ditherer 50 is driven bya motor (not shown in FIG. 1A) which may be located on-board the roboticinstrument driver 400 or, in other embodiments, off-board the roboticinstrument driver 400 as a separate dithering actuation subsystem. Inthe depicted variation, the mechanical ditherer 50 dithers or causesreciprocating axial movement of the working instrument 30 relative tothe guide instrument 4 and sheath instrument 6. For example, FIG. 1Aillustrates the distal end 34 of the working instrument 30 ditheringback and forth in the direction of arrow “C”. The length or stroke ofthe dithering may be adjusted depending on the nature of the procedurebut generally is less than a few millimeters. In some embodiments, thestroke of the dithering may be less than about 1.5 mm.

The mechanical ditherer 50 comprises at least one force sensor (notshown in FIG. 1A) that is used to detect the force or load that is beingapplied to the proximal portion of the working instrument 30. The forcesensors are able to determine the insertion and withdrawal forcesapplied to the working instrument 30 via the mechanical ditherer 50.Over one or more dithering cycles, these force profiles or waveforms canbe used to accurately estimate contact forces at the distal end 34 ofthe working instrument 30. For example, FIG. 1A shows the distal end 34in close proximity to an anatomical surface 70 which may comprise, forinstance, cardiac tissue. Of course, contact forces may also come fromother objects in the vicinity of the distal end 34 such as, forinstance, medical instruments or the like.

Still referring to FIG. 1A, a flexible bellows 60 connects the distalend of the Touhy seal 40 to the proximal end of the guide instrument 4.In this regard, the flexible bellows 60 compresses and expands as theworking instrument 30 is dithered with respect to the guide instrument 4and sheath instrument 6. The flexible bellows 60 may be connected to afluid line 64 that is connected to a source of pressurized saline or thelike. During use of the robotic instrument system 2, the pressurizedsaline is pumped into the space between the exterior of the workinginstrument 30 and the interior of the guide instrument 4 to preventbackflow of blood or other bodily fluids which, if allowed to retrogradeinto the guide instrument, could disrupt the ability to dither theworking instrument 30 inside the guide instrument 4. Additional fluidlines 66, 68 may be coupled, respectively, to the guide instrumentsplayer 14 and sheath instrument splayer 16 to provide lubricationbetween guide instrument 4 and sheath instrument 6.

While FIG. 1A illustrates the mechanical ditherer 50 being coupled tothe Touhy seal 40 it should be understood that the mechanical ditherer50 also may be coupled directly to a proximal region of the workinginstrument 30. FIG. 1A also illustrates a second clamp 58 that is usedto secure the handle 36 of the working instrument 30 to the roboticinstrument driver 400. In this regard, inadvertent movement of thehandle 36 does not affect the force sensing capabilities of themechanical ditherer 50. The handle 36 is isolated or grounded from theload sensing aspect of the mechanical ditherer 50 which is discussed inmore detail below.

By “dithering” the working instrument 30 with respect to the guideinstrument 4, the repeated cyclic motion may be utilized to overcomefrictional challenges normally complicating the measurement, from aproximal location, of loads at the distal end 34 of the workinginstrument 30 when in contact with a surface. In one embodiment, thedithering motion may be applied on a proximal region of the workinginstrument 30 as is illustrated in FIG. 1A and near the location atwhich relative axial load is measured. In other words, for example, if auser were to position a working instrument 30 down a lumen 8 of a guideinstrument 4 so that the distal end 34 of the working instrument 30 issticking out slightly beyond the distal end 18 of the guide instrument4, and have both the guide instrument 4 and working instrument 30threaded through the blood vessel(s) from a femoral location to thechambers of the heart, it may be difficult to sense contact(s) andforce(s) applied to the distal end 34 of the working instrument 30 dueto the complications of the physical relationship with the associatedguide instrument 4. In particular, in a steady state wherein there islittle or no relative axial or rotational motion between the workinginstrument 30 and guide instrument 4, the static coefficient of frictionis applicable, and there are relatively large frictional forces keepingthe working instrument 30 in place adjacent to the guide instrument 4(no relative movement between the two).

To release this relatively tight coupling and facilitate proximalmeasurement of forces applied to the distal end 34 of the workinginstrument 30, dithering motion may be used to effectively break loosethis frictional coupling. In one embodiment, such as the one illustratedin FIG. 1A, the dithering motion may be applied on a proximal region ofthe working instrument 30. In still other embodiments (not shown), itmay be possible to dither the guide instrument 4 with respect to astationary or substantially stationary working instrument 30. In yetanother embodiment, both the guide instrument 4 and working instrument30 may be dithered with respect to one another.

It should also be understood that FIG. 1A illustrates longitudinaldithering of the working instrument 30 with respect to the guideinstrument 4. It is possible in alternative embodiments to dither theworking instrument 30 radially with respect to the guide instrument 4.Alternatively, the guide instrument 4 could be dithered radially withrespect to the working instrument 30. In yet another alternative, theguide instrument 4 and working instrument 30 could both be dithered inthe radial direction at the same time.

The dithering embodiment illustrated in FIG. 1A avoids some of thecomplexities associated with using custom-made working instrumentshaving embedded, distally-located sensors and instead facilitates theuse of standard off-the-shelf working instruments 30. Thus, withoutaltering the working instrument 30, by dithering the proximal region ofthe working instrument 30, either directly or via the seal 40, andplacing the force sensors at the proximal region of the workinginstrument 30 it is possible to measure the estimated force that isapplied at the distal end 34 of the working instrument 30. By ditheringthe working instrument 30, the same is in motion substantially all ofthe time, and applied forces are shown in the force readings asincremental forces, thus substantially eliminating the effects of staticfriction after data processing has been executed, which is described inmore detail below.

Still referring to FIG. 1A, the robotic instrument system 2 may comprisean all stop button 74 that is used to terminate activity of the roboticinstrument driver 400 when depressed. The button 74 thus acts as asafety feature should one or more aspects of the device fail requiringmanual user intervention.

FIG. 1A also illustrates a user interface 80 that is operativelyconnected to the robotic instrument driver 400 and instrument set. Thephysician or other user interacts with the user interface 80 to operatethe robotic instrument driver 400 and associated guide 4 and/or sheath 6instruments, and associated working instrument 30. The user interface 80may be connected to the robotic instrument driver 400 via a cable or thelike. Alternatively, the user interface 80 may be located in ageographically remote location and communication is accomplished, atleast in part, over a wide area network such as the Internet. Of coursethe user interface 80 may also be connected to the robotic instrumentdriver 400 via a local area network or even wireless network that is notlocated at a geographically remote location.

FIG. 1A also illustrates a display 90 that is used to display variousaspects of the robotic instrument system 2. For example, an image of theguide instrument 4, sheath instrument 6, and working instrument 30 maybe displayed in real time on the display 90 to provide the physicianwith the current orientation of the various devices as they arepositioned, for example, within a body lumen or region of interest. Asalso shown in FIG. 1A, the display 90 may include a readout on theestimated force experienced by the distal end 34 of the workinginstrument 30. For example, the readout may include graded scale 92 witha moveable arrow 94 that rises or falls as the force changes. Thedisplay 90 may also include a visual cue 96 indicating the amount oferror associated with the estimated force. The visual cue 96 may includeerror bars as shown in FIG. 1A. Alternatively, the visual cue 96 mayinclude a separate scale or graph that illustrates real time error inthe measured force. The visual cue 96 may also include a color change tothe arrow 94. In still another alternative, the visual cue or graphicalelement 96 may include a warning indicator or textual message.

In addition, the display 90 may include a visual cue or signal that ispresent when the error exceeds a pre-determined threshold value (e.g.,+/−20% or +/−20 grams). The estimated measured force at the distal end34 of the working instrument 30 may also be compared with apre-determined threshold value. For example, if too much pressure isbeing applied to the distal end 34, an audible warning signal may beinitiated. Alternatively, a visual signal such as a graphical element 98may be shown on the display 90. In still another aspect, a haptic signalmay be returned to the user, for example, a vibrational signal that canbe felt by the user.

FIG. 3 illustrates a user interface 80 located at an operator controlstation 82 located remotely from an operating table 84 having a movablesupport-arm assembly 86. The support assembly 86 is configured tomovably support the robotic instrument driver 400 above the operatingtable 84 in order to position the guide instrument 4, sheath instrument6, and working instrument 30 (not shown in FIG. 3). A communication link86 transfers signals between the operator control station 82 and therobotic instrument driver 400.

Referring now to FIG. 4, a view of another variation of an operatorcontrol station 82 is depicted having three displays 90, a touch screenuser interface 100, and a control button console 102. The control buttonconsole 102 may comprise a button 103 a that is used to turn the forcesensing capability on or off. In addition, the control button console102 may comprise a dedicated button 103 b that is used to baseline therobotic instrument driver 400 or associated instrument set. Of course,these functions may be implemented instead via the touch screen userinterface 100. The operator control station 82 comprises master inputdevice 104 that is manipulated by the physician to translate movement tothe robotic instrument driver 400 and associated instruments. Alsodepicted in FIG. 4 is a device disabling switch 106 configured todisable activity of the instrument temporarily. The cart 108 depicted inFIG. 4 is configured for easy movability within the operating room orcatheter lab, one advantage of which is location of the operator controlstation 82 away from radiation sources, thereby decreasing radiationdosage to the operator.

FIGS. 5-11 illustrate schematically various methods of accomplishingforce estimation at the distal end 34 of a working instrument 30 byusing a dithering technique. FIG. 5 illustrates an embodiment in whichthe working instrument 30 dithers with respect to substantiallystationary guide instrument 4. In order to dither the working instrument30 back and forth (longitudinally), the mechanical ditherer 50 willdrive the working instrument 30 through a force sensor 110 which willmeasure the direct force needed to insert and withdraw the workinginstrument 30 in and out of the guide instrument 4. The ditherer 50 ismechanically grounded (via a mechanical linkage 52) to a proximal region35 of the guide instrument 4 and is thus stationary to the guideinstrument 4 but the force sensor 110 and working instrument 30 movetogether relative to the guide instrument 4. Readings from the forcesensor 110 may be sent through conditioning electronics 114 then to acomputer 118 for data processing, and finally to a display 122.

FIG. 6 illustrates an alternative embodiment in which the ditherer 50and force sensor 110 are mechanically linked to a seal 40 such as aTouhy seal. The Touhy seal 40 acts as a fluidic seal which can addsignificant and erratic drag to the reciprocating in-and-out motion ofthe working instrument 30 which would adversely affect the accuracy ofreadings from the force sensor 110. The embodiment of FIG. 6 eliminatesthis effect by mechanically securing or locking the Touhy seal 40 to theworking instrument 30 so the two are dithered together. In addition,FIG. 6 illustrates the flexible bellows 60 that is connected to theproximal end of the guide instrument 4 at one end and secured to theTouhy seal 40 at the other end. The bellows 60 includes a flush line 64that is used to delivery pressured saline as described herein. Thebellows 60 expands and contracts like an accordion with the ditheringmotion. The bellows 60 advantageously applies a very low drag force onthe working instrument 30 during the dithering motion as opposed to thehigh drag force that would be applied if the working instrument 30 wasdithered through the Touhy seal 40.

FIG. 7 illustrates yet another embodiment which further secures orgrounds a handle 36 of the working instrument 30. Generally, disposableworking instruments 30, such as the ablation catheters available fromsuch suppliers as Boston Scientific and Biosense Webster under tradenames such as “Blazer™” and “NaviStar™” are typically manufactured witha handle 36 located on their proximal end. Unsecured, this handle 36would likely apply forces on the Touhy seal 40 and/or working instrument30 that would be read by the force sensor(s) 110 and perhaps mistakenlybe interpreted as applied forces at the distal end 34 of the workinginstrument 30. Because of this, in the embodiment illustrated in FIG. 7,the handle 36 is isolated or guarded from the Touhy seal 40 and theforce sensor(s) 110. The “guarding” may be accomplished by securing theinstrument handle 36 into a holder such as the clamp 58 as shown in FIG.1A.

The handle 36 may be grounded in one of a number of ways. One variationis to physically ground the handle 36 to the guide instrument 4 as shownin FIG. 7. In this case the handle 36 would be stationary relative tothe guide instrument 4. As another alternative, the handle 36 may begrounded to a common carriage or mounting plate on which the guide andsheath instrument splayers 14, 16 are mounted. In this configuration thehandle 36 is again grounded with respect to the guide instrument 4albeit indirectly via a common carriage or mounting plate.

FIG. 8 illustrates another embodiment in which the handle 36 is securedto the mechanical ditherer 50 via a securing member such as a clamp. Inthis embodiment, the handle 36 would dither along with the Touhy seal 40and the working instrument 30. It is important to note that the forceused to dither the handle 36 back and forth does not go through theforce sensor(s) 110 and so any forces needed to move the handle 36 (orany accidental forces applied to the handle 36) are not seen by theforce sensor(s) 110. Consequently, in this case, the handle 36 would becompletely guarded within the system and there would be no periodicoffset force.

In one embodiment, a drape 130 may be used to isolate non-sterileequipment from the sterile, surgical environment. In this regard, thedrape 130 may cover the ditherer 50. If the drape 130 is attached to theforce sensor(s) 110 and happens to catch on a person or equipment, itmay pull on the force sensor(s) 110 and add an unwanted forcemeasurement (e.g., artifact). Because of this, the portion of the drape130 that is around the force sensor(s) 110 preferably is guarded—in thiscase by attaching it to a rigid ring 132, comprising materials such asmetals or polymers, that surrounds the force sensor(s) 110 and Touhyseal 40. The guard ring 132 may be attached to the system with anynumber of methods.

As shown in FIG. 9, the ring 132 is attached to a point where the drape130 dithers along with the working instrument 30. Thus, accidental pullson the drape 130 (outside of the drape guard 132) generally are nottransferred into the force sensor(s) 110 (but is transferred to theditherer 50) and preferably does not result in a false forcemeasurement. Another variation is illustrated in FIG. 10 in which thedrape guard ring 132 is secured to the guide instrument 4. Consequently,an accidental pull on the drape 130 (outside of the drape guard ring132) advantageously is transferred into the stationary guide instrument4 and not into the force sensor(s) 110. In this embodiment, there may bea small amount of movement between the Touhy seal 40 and/or forcesensor(s) 110 (which is dithered) and the stationary guard ring 132,which will may cause bunching and stretching of the drape 130 inside theguard ring. The drape 130 preferably is very compliant and thisdifferential motion causes a small amplitude periodic force which issubstantially the same during insertion and withdrawal and may thus besubtracted in subsequent force sensing data processing.

FIG. 11 illustrates one embodiment of a drape 130 that is shown loadedonto a robotic instrument driver 400. The drape 130 includes platformcovers 134 having a series of holes which are used to mount the splayers14, 16. Also, proximal of the platform cover 134 for the guideinstrument splayer 14 is a flexible boot 136 made of a very flaccidrubber or polymeric material that is surrounded by a ring 133 ofsemi-rigid material. The ring 133 is secured to the robotic instrumentdriver 400 such that any pulling, tugging, or other forces aretransmitted through the drape 130 to the robotic instrument driver 400and not the flexible boot 136. For example the semi-rigid ring 133 maybe secured to the grounded drape ring 132. In this regard, the boot 136and ring 133 isolate forces on the drape 130 from affecting the forcemeasurements obtained using the force sensors 110. The workinginstrument 30 passes through the flexible boot 136 and can be secured tothe ditherer 50.

As mentioned above, a different variation of dithering comprisesdithering the working instrument 30 rotationally as opposed tolongitudinally or axially. As seen in FIG. 12, the force sensor(s) 110would no longer be in series with the mechanical ditherer 50. Rather,the ditherer 50 would in this case be rotational and because it is anorthogonal motion (relative to the in-and-out motion due to the distalend force which may be applied to the working instrument 30), theorthogonal forces may be isolated from one another by using a bearing 48allowing the force sensors 110 to measure the applied force at thedistal end 34 as isolated from the forces caused by the rotationaldithering motion.

Regardless of whether the dithering motion is rotational orlongitudinal, the structure of the flexible bellows 60 facilitates theoperation of this dithering force measurement system. For example, inthe longitudinal embodiment, the bellows 60 provides low force from thelongitudinal dithering and is volumetrically compliant to allow for thechange of flush volume within the bellows 60 during the ditheringprocess. In the rotational dithering embodiment, the bellows 60 isconfigured to allow for rotation of the ends of the bellows 60 while notcreating a significant longitudinal force offset to the force sensor(s)110.

FIG. 13 illustrates a perspective view of a robotic instrument system 2according to one embodiment of the invention. The robotic instrumentsystem 2 includes a housing 150 that is partially exposed in FIG. 13.The robotic instrument system 2 generally comprises a carriageconfigured to interface with structures coupled to or comprising theguide instrument splayer 14, and a carriage configured to interface withstructures coupled to or comprising the sheath instrument splayer 16.Longitudinal slots 154 defined by the outer housing 150 of the roboticinstrument driver 400 are configured to facilitate longitudinal movementof the carriages and associated splayers 14, 16 relative to the outerhousing 150 of the robotic instrument driver 400

FIG. 14 illustrates a magnified perspective view of the distal portionof the robotic instrument system 2. The guide instrument 4 and sheathinstrument 6 are not shown for clarity purposes. As seen in FIG. 14, theclamp 54 for the Touhy seal 40 may comprise a rotatable handle 140 thatis used to frictionally hold the Touhy seal 40 in place. For example,the clamp 54 may comprise a lower seat 156 that is positioned on theload bearing aspect of the ditherer 50 and an upper clamping member 158that, when tightened via the handle 140, frictionally secures the Touhyseal 40 in a sandwich arrangement. The handle 140 may comprise a grooveor notch 142 that can be used to temporarily secure a flush line or thelike.

FIG. 14 also illustrates a clamp 58 for the handle 56 of the workinginstrument 30 that also comprises a rotatable handle 144 that is used tofrictionally secure the handle 36 of the working instrument 30 in place.The clamp 58 may comprise a lower seat 160 that is fixedly secured tothe carriage (or a support member secured to the carriage) and an upperclamping member 162 that, when tightened via the handle 144,frictionally secures the proximal handle 36 in a sandwich arrangement.The rotatable handle 144 comprises a groove or notch 146 that can beused to temporarily secure a flush line or the like.

FIG. 15 illustrates an assembly drawing of the guide instrument splayer14 along with the mechanically coupled mechanical ditherer 50. A workinginstrument 30 is shown being inserted into the proximal end of the Touhyseal 40. The distal end 34 of the working instrument 30 is not shown inFIG. 15. The Touhy seal 40 of FIG. 15 illustrates a proximal end havinga series of threads 42 on which is mounted a cap 44 which is illustratedin, for example, FIGS. 13, 14, 15 (showing threads 42), 16, and 17). Thecap 44 may be tightened on the threads 42 to form a fluidic seal thatprevents fluid from escaping between the interface of the seal 40 andthe working instrument 30. FIG. 15 also illustrates a conduit 65 that isconnected to the interior of the Touhy seal 40. The conduit 65 isconnected to a source of pressurized flush solution 76 which maycomprise, for instance, pressurized saline. A pressure regulator 78 orthe like may be interposed in the conduit 65 between the pressurizedflush solution 76 and the Touhy seal 40 to ensure that a constantpressure of fluid is applied. Of course, in other embodiments, theconduit 65 may be fluidically coupled to the flexible bellows 60.

FIGS. 16 and 17 illustrate perspective views of the robotic instrumentsystem 2 having a working instrument 30 being inserted into the Touhyseal 40. The working instrument 30 passes through the lumen 8 of theguide instrument 4 and the lumen 10 of the sheath instrument 6. Thehandle 36 of the working instrument 30 is secured to the roboticinstrument driver 400 via the clamp 58. FIGS. 16 and 17 also illustratea flush line or conduit 65 that is held in place via the groove 146 inthe handle 144. With reference to FIGS. 16 and 17, the workinginstrument 30, which in certain embodiments may include an off-the-shelfsteerable or nonsteerable catheter, may include a steering member 31located on the handle 36. In this case, the steering member 31 ispreferably placed into a neutral position to permit steering by therobotic instrument driver 400.

FIGS. 18A-C illustrate various aspects of the mechanical ditherer 50according to one embodiment. FIG. 18A illustrates a guard ring or cage170 that is mounted to a moveable dither carriage 180 (as seen in FIGS.18B and 18C). The guard ring 170 may be secured via mounting pads 172having holes therein for passage of a screw, bolt, or the like (notshown) that mates with respective holes 182 in the dither carriage 180.The guard ring 170 may include additional holes 176 on a top surfacethereof for mounting, for example, the drape 130. In this regard, thedrape 130 dithers along with the working instrument 30. Any accidentalpull on the drape 130 would not be transferred into load cells and wouldnot result in a false force measurement.

FIG. 18B illustrates the load bearing member 190 of the mechanicalditherer 50. The load bearing member 190 is pivotally mounted to thedither carriage 180. The load bearing member 190 pivots about pivotpoint 192 in the manner of an inverted pendulum. The pivot point 192 mayinclude a shaft 194, pin, bearing or the like that permits ditheringmovement of the load bearing member 190 along with the dither carriage180. The dithering motion causes movement of the dither carriage 180 andattached load bearing member 190 in the direction of arrow A in FIG.18B. Two load cells 200 (one of which is illustrated in FIG. 18B) arepositioned on either side of the load bearing member 190 and eachcontain a force sensor 204. FIG. 19 illustrates a perspective view ofthe dither carriage 180 including the load cells 200 having therespective force sensors 204 loaded therein. As best seen in FIGS. 18Band 18C, the load bearing member 190 is fixedly secured to the dithercarriage 180 via the pivot point 192 and moves along therewith duringthe dithering movement.

The two force sensors 204 measure compressive forces. In particular, thetwo force sensors 204 output a small voltage that is proportional to orcorrelates with the applied force. The load bearing member 190 comprisesthe seat 156 onto which is mounted the Touhy seal 40 (or in otherembodiments the working instrument 30). As the dither carriage 180 ismoved back and forth in the reciprocating manner, the forces experiencedon the proximal end of the working instrument 30 (or Touhy seal 40) arethen measured via the output signals on the two force sensors 204. Theload bearing member 190, which swings back-and-forth in a pendulum-likemanner, alternatively makes contact with the opposing force sensors 204.When the load bearing member 190 does not contact a force sensor 204,the force sensor 204 outputs a baseline or zero signal (e.g., novoltage).

The analog voltage signal from each force sensor 204 is amplified via anamplifier (not shown). The amplified signal may then pass through a flexcircuit on the robotic instrument driver 400 structure to one or morecircuit boards (not shown) mounted to the carriage or chassis. Theanalog signal then is transformed into a digital signal via ananalog-to-digital converter (ADC). The digital signals can then bepassed to an off-board computer located, for example, at the operatorcontrol station 82. The operator control station 82 may then convert thedigital data into a usable form using, for example, the single cyclesubtraction algorithm described in more detail below. The separation ofthe load cells 200 is dimensioned such that there is a relatively smallgap between the load cells 200 and the load bearing member 190 as thereis a small dead band created when the load bearing member 190 is nottouching either of the two opposing force sensors 204.

Referring to FIGS. 18B and 18C, the dither carriage 180 is secured totwo c-shaped channels 184. The channels 184 engage with correspondinglydimensioned rails (not shown) such that the entire dither carriage 180is able to move back-and-forth in the direction of arrow A in FIG. 18B.

FIG. 20 schematically illustrates the load bearing member 190 movingabout pivot point 192 between the opposing load cells 202 holding theforce sensors 204. The pivot point 192 may include a stationary shaft194 that is mounted with respect to the opposing load cells 202. Forexample, as seen in FIG. 19, the shaft 194 may be driven through thebase of both load cells 202. The load bearing member 190 is sandwichedbetween the two load cells 202 and is held on the shaft 194 via bearings196 or the like that allows rotational motion of the load bearing member190 pivot about the shaft 194. Since the pivot 192 ultimately holds theworking instrument 30, force felt by the working instrument 30 willcause the load bearing member 190 to rotate about pivot point 192 andpress up against (e.g., compress) one of the force sensors 204. Theforce sensors 204 measure this pivot force from which instrument forcefeedback can then be calculated.

The mechanical ditherer 50 will dither the load cells 200 back and forth(in a linear displacement fashion approximately 1.5 mm frompeak-to-peak). Of course other stroke lengths are also contemplated. Asthe mechanical ditherer 50 changes direction, the load bearing member190 rotates a very small amount to exchange force from one force sensor206 to the other force sensor 206 then the linear motion of the ditherercarriage 180 continues to carry the load bearing member 190 in a linearmotion which pushes in or pulls out the working instrument 30. The loadbearing member 190 acts as a static lever arm. By using two forcesensors 204, each can be used to verify that the other force sensor 204is working properly. For example, the dead band zone where the loadbearing member 190 is not touching either force sensor 204 occurs onceper dither cycle and is used to confirm the force sensor 204 “zero load”position and to test proper force sensor 204 operation.

Extremely large forces will not be sensed by the force sensors 204 butwill be transferred directly to the load cell mounts 200 so as toprotect the force sensors 204 from damage. The load cell mounts 200 aredesigned to protect the force sensors 204 from excessive forces from theload bearing member 190 (excessive forces applied to a force sensors 204may permanently damage them leading to incorrect force readings). Toachieve this protection the load cell mounts 200 may have a precisionground cup into which the force sensor 204 sits. The depth of this cupmay be just slightly shorter than the height of the force sensor 204sitting in it, so that as the load bearing member 190 rotates to theforce sensor 204 and load cell mount 200 it will push on the forcesensor 204 at first. As additional force is applied by the load bearingmember 190, the force sensor 204 (which has a very slight amount ofcompliance) reduces in height until the load bearing member 190 strikesthe load cell mount 200. Thus, by controlling the depth of the precisionground cup in the load cell mount 200 and by knowing the compliance ofthe force sensor 204 in compression, the maximum force applied to theforce sensor 204 can be set, which will protect the force sensor 204excessive forces. Other methods of protecting the force sensors 204 canbe achieved by using shims or fine pitched screws to adjust for thepoint where forces to the force sensors 204 are shunted anyway. Theforce sensors 204 themselves may be uni-directional compression forcesensors (sometimes referred to also as load cells) rated at 5 lbs (e.g.,available from Honeywell Sensotec-Lebow of Ohio).

FIGS. 21A and 21B illustrate an exemplary waveform of the measured orobserved forces using the force sensors 204 through a single dithercycle. The single dither cycle includes a single insertion strokefollowed by a single withdrawal stroke. Positive forces are thosemeasured during insertion while negative forces are those measuredduring withdrawal. In the embodiment described above, one force sensor204 is used to measure insertion forces while the other, opposing forcesensor 204 is used to measure withdrawal forces. As seen in FIG. 21A,the applied force increases in a substantially linear manner until theforce plateaus. The point at which the force begins to plateau is takenat that point when the working instrument 30 begins to dither axiallywith respect to the guide instrument 4. After a period of constant orsubstantially constant force, the force then begins to decrease in asubstantially linear manner. The force then goes “negative” as theworking instrument 30 is withdrawn from the guide instrument 4. Theforce then plateaus at a negative value before returning to the origin.

FIG. 21A illustrates a condition in which no force is applied to thedistal end 34 of the working instrument 30. FIG. 21A illustrates twosuch waveforms (solid line 210 and dashed line 212). Both waveforms,while having different amplitudes, are substantially symmetrical. Thisfeature is particularly advantageous because the forces are symmetricalin nature, the resulting waveform shows an equal force on insert and onwithdrawal. Consequently, in processing the obtained force measurementdata from the force sensors 204, it is possible to take a one cycleaverage of the waveform that will eliminate the substantiallysymmetrical offset forces from the measurement leaving only thedifferential shift in force. This differential shift in force is theforce that is applied at the distal end 34 of the working instrument 30.Consequently, measured or observed forces at the proximal region 35 ofthe working instrument 30 may be used to accurately and consistentlyestimate forces applied to the working instrument 30 at the distal end34.

FIG. 21B illustrates a first or “baseline” waveform 216 (solid line)taken when no force is applied to the distal end 34 of the workinginstrument 30. FIG. 21B also shows the waveform 218 (dashed line) takenwhen a force is applied to the distal end 34 of the working instrument30. As seen in FIG. 21B, the entire curve is shifted in the upwarddirection. With reference to FIG. 21B, the amplitude d₁ is now largerthan the amplitude d₂. This difference between the baseline measurementand the measurement obtained upon application of a force may be used toquantify the force applied to the distal end 34 of the workinginstrument 30.

FIG. 22 illustrates a baseline waveform 216 (dashed line) along with anoverlaid waveform 218 (solid line) obtained when a force is applied tothe distal end 34 of a working instrument 30. According to oneembodiment, a portion 220 of the plateau region of both the baselinewaveform 216 and the waveform 218 created from the contact force aresampled in regular increments. For example, the force readouts from thesensors 204 may be sampled at one millisecond increments over theirentire cycle. While the entire waveform may be sampled, differentembodiments may choose to ignore portions of the sampled waveform. Forexample, in one embodiment, only those portions 220 of the plateaus arekept or utilized for the force algorithm with the remaining readoutfigures being ignored or deleted. The portion 220 of the waveformplateau may include a partial segment of the waveform that eliminatesthe endpoints as is shown in FIG. 22.

With respect to the algorithm, baseline force measurements are obtainedat the baseline sampling locations in the plateau regions 220 for boththe insertion stroke and the withdrawal stroke with no force applied ondistal end 34 of working instrument 30. An average force measurement isthen obtained for each binned series of baseline data for both theinsertion and withdrawal strokes. For generation of the baselinenumbers, the average force measurements within the plateau regions 220may be averaged over a number of cycles, for example, three cycles. Asseen in FIG. 22, sampled force measurements are also obtained over theplateau regions 220 with the working instrument 30 being subject to aforce on the distal end 34. Force measurements obtained over the binnedinsertion period are then averaged and subtracted from the averagebaseline force described above to produce an Update A value. The UpdateA value corresponds to the difference of the average forces obtainedfrom the working instrument 30 under the insertion stroke with forceapplied and under insertion stroke with no force applied (i.e.,baseline). Similarly, force measurements obtained over the binnedwithdrawal period are then averaged and subtracted from the averagebaseline withdrawal force described above to produce an Update B.

The estimated force on the distal end 34 of the working instrument 30may then be calculated by the following formula:

Force_(Est.)=(Update A+Update B)/2  (1)

Under this algorithm, Update A is determined at the completion of theinsertion portion of the stroke while Update B is determined at thecompletion of the withdrawal portion of the stroke. For example, for adithering rate of 2 Hz, the values (Update A or Update B) are updatedabout every ¼ second. Thus, as time progresses, Update A is updated,then Update B, then Update A, and so on and so forth. After each updatestep, the force value is re-calculated. It should be understood that adither rate may be altered as needed. For example, in certainembodiments, the dither rate may vary between 0 Hz and about 10 Hz.

While the algorithm described above uses a single cycle differentialaverage of selected portions of the waveforms obtained during a contactstate and a non-contact state there are other ways of obtaining similarinformation. For example, the averages may be calculated over more thanone cycle. In addition, the estimated force may be obtained by comparingthe profile or shape of the measured waveforms when the workinginstrument is in a contact state (e.g., experiencing a force) with themeasured waveform obtained in a baseline state (e.g., no force). Forinstance, other embodiments might consider waveform slope,representative of mechanical stiffnesses in the system, as an indicatorfor which portion of the waveform contains useful data (i.e., signal)and which portion of the waveform is superfluous (i.e., noise).

FIG. 23 illustrates a perspective view of a chassis 230 on which theguide splayer 14 (not shown) is mounted. FIG. 23 further illustrates thepivotable lever arm 232 that mechanically connected to the dithercarriage 180. As best seen in FIGS. 23 and 24, the lever arm 232includes a hole 234 for receiving a bearing 236 that is mounted to asurface (e.g., top surface) of a pulley 238. During the ditheringoperation, the lever arm 132 pivots about pivot point 240 which is therotational axis of the bearing 236. The lever arm 232 further includes aslot 242 that traverses a portion of the length of the lever arm 232.The slot 242 is dimensioned to receive a bearing 244 mounted in aneccentric manner on a pulley 246. As best seen in FIG. 24, the bearing244 is mounted in an eccentric or offset manner by using a cam 248 thatis affixed to the upper surface of the pulley 246 by, for instance,screws 250. The cam 248 may be “T-shaped” and include a pin or shaft 249on which the bearing 244 is mounted. Different cams 248 having differentdistances between the center of rotation of the pulley 246 to the pin249 may be used to alter the degree of eccentricity. This, in turn,would alter the stroke distance of the mechanical ditherer 50.

Still referring to FIGS. 23 and 24, the lever arm 232 includes anotherslotted portion 252 in a central region of the lever arm 232. Theslotted portion 252 is generally oriented longitudinally along thelength of the lever arm 232. The slotted portion 252 is dimensioned toreceive a bearing 254 this is rotationally mounted to the dithercarriage 180. The bearing 254 may be positioned on a mount 256 thatelevates a portion of the dither carriage 180.

As seen in FIG. 23, the dither carriage 180 is mounted to the chassis230 using two crossed roller slides 258. The crossed roller slides 258includes a base 260 that is fixedly secured to the chassis 230 and aninner slidable carriage 262 that is coupled to the dither carriage 180.A series of bearings or cylindrical steel rollers (not shown) enablesthe carriage 262 to glide, almost friction-free, over the base 260. Forexample, the cross roller slides 258 may be obtained from Del-Tron Inc.,5 Trowbridge Drive, Bethel, Conn. 06801 (model no. RD-1).

The pulleys 238, 246 used to drive the lever arm 232 include acircumferential groove 266 that is used to hold a drive cable 270 (shownin FIG. 25). The drive cable 270 may be formed from a bundle of numeroussmaller wires formed from, for example, tungsten. As an example, thedrive cable 270 may have an 8×19 construction formed from 152 wireshaving a diameter of 0.008″ that results in a drive cable 270 having anoverall diameter of around 0.018.″ The pulleys 238, 246 also include aplurality of recesses 268 that formed in the groove 266 and are used tomate with regular spaced crimp balls 272 that located along the lengthof the drive cable 270. The use of the crimp balls 272 along with themating recesses 268 ensures that there will be no slippage between thedrive cable 270 and the pulleys 238, 246 during the dithering process.

FIGS. 26 and 27 illustrate top down plan views of the lever arm 232 andditherer 50 as the lever arm 232 is pivoted back and forth in thewithdrawal and insertion strokes. FIG. 26 illustrates the eccentricallyoffset bearing 244 in roughly a “six o'clock” position wherein the leverarm 232 is at or near the maximal displacement in the proximaldirection. The lever arm 232 in FIG. 26 is thus at the beginning of theinsertion stroke or, alternatively, the end of the withdrawal stroke. Incontrast, FIG. 27 illustrates the eccentrically offset bearing 244 inroughly a “twelve o'clock” position wherein the lever arm 232 is at ornear the maximal displacement in the distal direction. The lever arm 232in FIG. 27 is thus at the beginning of the withdrawal stroke or,alternatively, the end of the insertion stroke.

Referring now to FIGS. 28 and 29, a motor driven pulley system 280 isused to pivot the lever arm 232 back and forth which, in turn, causesthe reciprocating motion of the mechanical ditherer 50. As best seen inFIG. 29, the drive cable 270 is secured to a motor 282 having positionedthereon a drive pulley 284. The drive pulley 284 is secured to a shaft283 of the motor using a clamp 287. The motor 282 is secured to, forexample, a chassis 285 of the robotic instrument driver 400. The motor282 may be mounted so as to be stationary with respect to the chassis230 holding the lever arm 232. An encoder 281 is affixed to the backsideof the motor 282 as seen in FIG. 29 and is used to accurately determinethe position of the shaft 283 at any given point of time.

As seen in FIGS. 28 and 29, the drive cable 270 then passes through aseries of proximally positioned pulleys 286. The pulley system 280 mayalso include a tensioning pulley 288 that is used to provide a biasingforce, for example, via springs 290, to ensure that the drive cable 270remains taught. The tensioning pulley 288 may be used to provide tensionto the drive cable 270, for example, if the guide splayer 14 were movedlongitudinally. As seen in FIGS. 28 and 29, the crimp balls 272positioned along the length of the drive cable 270 ensure properregistration between the cable 270 and the various pulleys.

FIGS. 30A-30G, and FIGS. 31-33 illustrate another embodiment of amechanical ditherer 300. In this embodiment, a rotationally driven cam302 (best seen in FIGS. 30E and 30G) is used to drive pivoting holder304 that is secured to the guide instrument 30 and/or Touhy seal 40.FIGS. 30A and 30B illustrate a Touhy seal 40 that includes two tabs ordetents 306 that are used to mate with the pivoting holder 304. FIG. 30Cillustrates the pivoting holder 304 which includes a hole 307 at one endthereof that is used as the pivot point during operation of themechanical ditherer 300. The holder includes a main body section 308that includes an aperture 309 for the Touhy seal 40 along with recesses310 for the tabs or detents 306. The recesses 310 serve to properlyorient or register the Touhy seal 40 within the pivoting holder 304. Thepivoting holder 304 further includes a pin 312 or other projection thatis used to mate with a corresponding groove 314 located in therotationally driven cam 302, as is shown in FIGS. 30E and 30F. Thegroove 314 is spirally cut into the main, cylindrically-shaped body ofthe cam 302. Different cams 302 having grooves 314 with varying degreesof pitch may be used to adjust the stroke of the ditherer 300.

FIG. 30G illustrates the pivoting holder 304 and cam 302 contained in adither support block 316. The pivoting holder 304 may be pinned to thedither support block 316 via the hole 307 so as to permit pivoting aboutthe pivot point. The cam 302 is mounted via a shaft, axle, or the liketo supports 318 on the dither support block 316. FIG. 30G furtherillustrates a portion of the working instrument 30 passing through theTouhy seal 40 that is positioned within the pivoting holder 304.

FIG. 31 illustrates a top down view of the ditherer 300 being integratedinto the guide instrument splayer 14. As seen in FIG. 31, the Touhy seal40 may be secured at a distal end to a flexible bellows 60. The otherend of the bellows 60 may be coupled to the guide instrument 4. Alsoshown in FIG. 31 is a drive cable 320. The drive cable 320 is connectedat a proximal end to a motor, servo or the like (not shown) to power theditherer 300. The motor or servo may be located on-board the roboticinstrument driver 400 or off-board. The drive cable 320 may include, forexample, a bicycle cable that is rotationally driven back and forth.Rotational movement of the drive cable 320 may be translated to the cam302 which, in turn, causes the pivoting holder 304 to pivot back andforth. In one aspect, the groove 314 is cut in such a manner (e.g.,sinusoidal wave) that the cam 302 is rotated in a single direction tocause the back and forth movement of the pivoting holder 304. In thisregard, the drive cable 320 may be driven in a single direction. Inanother embodiment, the driven cable 320 may be driven in differentdirections to cause the cam 302 to rotate in different directions (e.g.,clockwise then counter-clockwise).

FIGS. 32A and 32B illustrate a magnified view of the ditherer 300 andits components as it dithers in and out. The pivoting holder 304 pivotsand follows the groove 314 in the cam 302 via the mechanically linkedpin 312 (obscured from view). In this embodiment, the Touhy 40 is thusmoved back and forth along with the pivoting holder 304. Because theworking instrument 30 is also securely fastened to the Touhy 40, theworking instrument 30 also is dithered back and forth. In order tomeasure the insert and withdrawal forces, a strain gauge 322 may bemounted to the pivoting holder 304 to measure stresses therein so theforce on the distal end 34 of the working instrument 30 can becalculated, for example, in the manner described herein.

FIG. 32B illustrates another embodiment for measuring force. In thisembodiment, force sensors 204 are disposed on opposing sides of thesupports 318 of the dither support block 316. The force sensors 204 mayinclude unidirectional force sensors as described herein. In theembodiment illustrated in FIG. 32B, there may be a dead band zone whenthe pivoting holder 304 is not contacting either force sensor 204. Thedisplacement of the pivoting holder 304 as well as the distances betweenthe force sensors 204 may be engineered to minimize this dead band zone.

FIGS. 33A-33G illustrate another embodiment of a mechanical ditherer330. In this embodiment, a dither assembly 336 includes an electricmotor or servo 332 that is used to directly drive a cam 334. The directdrive motor 332 is mounted to a base 350. The electric motor 332directly engages with a cam 334 that has a heart-shaped machined slot338 as illustrated in FIGS. 33C and 33E. A drive linkage 340 interfaceswith the cam 334 via a pin 342 (best seen in FIG. 33E) that travels inthe cam slot 338. The opposing end of the drive linkage 340 contains apin 344 that engages with the pivoting holder 346 that is secured to theTouhy seal 40. In this embodiment, as the electric motor 332 turns, themotor drives the cam 334, causing the pivoting holder 346 to pivot aboutits pin 348 (FIG. 33B) and translate back and forth to effectuate thedithering motion. FIG. 33G illustrates a base 350 that is used tosupport the various components of the dither assembly 336. Forcemeasurements may be obtained using either a strain gauge or one or moreforce sensors as described in the previous embodiment.

FIGS. 34A-34D illustrate various embodiments of how the estimated forceat the proximal end 34 of the working instrument 30 is displayed to thephysician or user. In one aspect, a force scale 400 is displayed on, forinstance, a display 90 (e.g., FIGS. 3 and 4) associated with theoperator control station 82. The force scale 400 may include a number ofgradations positioned at regular intervals. For instance, FIG. 34Aillustrates a force scale ranging from 0 grams to 100 grams of forcewith gradations every 25 grams. In one aspect, the user may control thescaling of the force scale 400 via a button, switch, menu or the like atthe operator control station 82. As seen in FIG. 34A, the magnitude ofthe estimated force at the distal end 34 of the working instrument 30 atany particular point in time is displayed via a bar 402. The bar 402rises or falls as the force dynamically changes. Advantageously, the bar402 is displayed in real-time or near real time as often as thealgorithm described herein is updated. Still referring to FIG. 34A, avisual cue 404 indicative of the estimated error in the measured forceis also displayed alongside the estimated force. In FIG. 34A, the visualcue 404 may include an error bar that is displayed alongside its ownforce scale 406 that indicates the amount of error associated with theparticular measurement. As seen in FIG. 34A, the error bar 404 combinestotal error with the baseline error on a single force scale 406. Thevisual cue 404 may be updated in real-time or near real-time as thealgorithm is updated. The system may be programmed such that if thebaseline error goes above a pre-determined threshold value, the user isprompted to re-baseline the device.

FIG. 34B illustrates an embodiment like that disclosed in FIG. 34A withthe difference being that only total error is displayed on the error bar404 adjacent to the force scale 406 associated with the error visual cue404. FIG. 34C illustrates another embodiment in which the baseline errorand total error are displayed as separate error bars 404 a, 404 b. FIG.34D illustrates still another embodiment in which a pointer 408 which,for example, is the form of an arrow or the like is used to display theestimated force. The pointer 408 dynamically moves up and down as forceis applied to the distal end 34 of the working instrument 30. In oneaspect, the pointer 408 may get larger as the force increases and,conversely, may get smaller as the force decreases. Also, the pointer408 may change color as the force dynamically changes. For example, thepointer 408 may appear to have a “hot” color (e.g., red) if theestimated force is relatively high. In contrast, if there were little orno force experienced by the working instrument 30, the color may be a“cool” color (e.g., blue). An intermediate level of force may be shownusing a medium color such as, for instance, yellow. In this regard, thephysician is given an extra visual cue as to the forces experienced bythe working instrument 30. FIG. 34D also illustrates a pointer 410 thatis used to display the estimated error in the force measurement. Likethe force measurement pointer 408, the error pointer 410 dynamicallymoves as the error changes. The error pointer 410 may also change colorin response to the degree of error. The estimated error may be displayedas a force (e.g., grams) or it may be displayed as a percentage ordegree of deviation.

The estimated error that is displayed to the physician is based on anumber of parameters that are empirically determined. For example, theestimated error may be based on the angle of the sheath 6, articulationangle, rate of change of articulation angle, insertion distance,peak-to-peak forces, as well as the magnitude of the forces applied tothe distal end 34 of the working instrument 30. The estimated error mayalso be a function of the type or model of working instrument 30 that isused. This information may be gathered and input via the operatorcontrol station 82. Information pertaining to the type of workinginstrument 30 as well as the empirical data may be stored in a memory orlook up table that can then be compared with measured force values tooutput an estimated error.

Other methods for displaying force may include using a sound where thetone, pitch, or volume varies according to the measured force.Additionally, an audible warning may sound if a force reading (or aseries of readings) reach a pre-determined, unsafe level. A warninglight or graphical element 96 (e.g., as shown in FIG. 1) or other typeof alert such as a warning dialogue box can indicate when the forcereaches unsafe levels. Haptic feedback can also indicate force increasesso that as force readings increase, proportional force is felt on themaster controller 104 at the operator control station 82. A vibrationalwarning may be sent through the master controller 104 so that thephysician feels a vibration when force levels have become unsafe.

With reference to FIG. 35, in a typical use of the device, the roboticinstrument driver 400 is first mounted (step 1000) with the drape 130 asillustrated, for example, in FIG. 11. The guide and sheath instrumentsplayers 14, 16 are loaded onto the robotic instrument driver 400 andinitialized as illustrated in step 1100. In one aspect of the method, asillustrated in step 1200 of FIG. 35, the working instrument 30 is loadedonto the robotic instrument system 2 and coupled to the ditherer 50prior to inserting and/or advancing (step 1400) the guide instrument 4and sheath instrument 6 into a body region (e.g., blood vessel) of thepatient. Alternatively, as illustrated in step 1300 of FIG. 35, theguide instrument 4 and sheath instrument 6 may first be inserted intothe body region of interest so as to place the distal tip of the guideinstrument 4 near or adjacent to the region or site of interest. As seenin step 1500 in FIG. 35, the working instrument 30 may then be backloaded through the seal 40 an into the guide instrument 4 until thedistal end 34 projects at least partially from the distal end of theguide instrument 4. A flushing fluid like pressurized saline may bepumped or forced in between the working instrument 30 and guideinstrument 4 to reduce friction and prevent retrograde flow through thedevice. Similar flushing fluids may be delivered between the guideinstrument 4 and the sheath instrument 6.

To use to force sensing feature of the robotic instrument system 2, thephysician or user may enable this functionality by, for example,pressing a button 103 a (FIG. 4) or by using the graphical userinterface (GUI) located at the operator control station 82. Thegraphical user interface (GUI) may include a touch screen 100 or anotherinput device such as mouse, keyboard, pencil, pointer, or the like.Initiation of the force sensing feature causes, for example, themechanical ditherer 50 to move back and forth and described herein.First, an initialization sequence is performed to establish a baseline.The process is represented as step 1600 in FIGS. 35 and 36. The systemmay prompt the physician or user to verify (e.g., step 2000 in FIG. 36)that the distal end 34 of the working instrument 30 is not contactingany objects (e.g., tissue, other instruments, etc.). For example, amessage may be displayed on the display 90 associated with the operatorcontrol station 82.

In one aspect of using the system described herein, the guide instrument4/sheath instrument 6 and working instrument 30 undergo the baselineprocess at an articulation position that closely approximates thearticulation that will be used during the diagnostic or therapeuticprocedure. For example, the guide instrument 4 with the workinginstrument 30 may be articulated into position in which the distal endof the working instrument 30 may contact a surface. The guide instrument4 and or sheath instrument 6 subsequently may be retracted proximally toensure that the distal end 34 of the working instrument 30 is free oftissue or other objects. Optionally, ECG or other diagnostic modalitiesmay be used to confirm that the distal end 34 of the working instrument30 is indeed free of any contact with tissue. Once the physician isconfident that the distal end 34 is free from any contact with tissue orobjects, the physician may then baseline the system by, for example,pressing a button 103 b (FIG. 4) or by using the graphical userinterface (GUI) located at the operator control station 82. The baselineis then taken and stored as illustrated in step 2100 of FIG. 36 for usein subsequent processing according to the algorithms described in detailherein.

If an unacceptable baseline measurement is taken, for example, if thesystem detects forces indicative of touching with a surface or object,the physician may be prompted with a warning that requests confirmationof the current baseline. For instance, a warning such as “There areindications that you are touching tissue. Are you sure you want toproceed?” may be displayed to the physician on the display 90. Thephysician may then re-baseline the system or, alternatively, accept thecurrent baseline. Once an acceptable baseline has been accepted by thephysician, the guide instrument 4 and/or sheath 6 and working instrument30 may be manipulated by the physician (step 1700 in FIG. 35) and theestimated force experienced at the distal end 34 of the workinginstrument 30 is preferably displayed (step 1800 in FIG. 35) to thephysician. In addition, a visual cue 404 or pointer 410 of the estimatederror may also be displayed as described herein with respect to FIGS.34A-34D.

The physician continues with the operation as desired with real-time ornear-real time display of the estimated contact forces experienced bythe distal end 34 of the working instrument 30. For example, theprocedure may include mapping heart tissue using a mapping catheter as aworking instrument 30. Alternatively, the procedure may include theablation of tissue using an ablation catheter as a working instrument30. While these two specific examples of procedures have been describedherein it should be understood, that the system is not limited to theparticular diagnostic or therapeutic procedure performed by the workinginstrument 30.

During the procedure, the computer(s) 118 or other processorsoperatively coupled to the robotic instrument system 2 may track theposition and/or orientation of the guide instrument 4, sheath instrument6, and working instrument 30 so that the physician may be prompted tore-baseline if the articulation meets or exceeds a pre-determinedthreshold value that has been established for movement of the guide 4instrument and/or sheath instrument 6. As explained with respect to FIG.1A, the articulation of the guide instrument 4, sheath instrument 6, andworking instrument 30 may be visualized by the physician on a display90. The underlying articulation data may optionally be displayed aswell. Likewise, as illustrated in step 2200 of FIG. 36, if the errorassociated with a particular force measurement is too large (e.g., abovea pre-determined threshold value), the system will prompt or suggest(step 2300) the physician to re-baseline the system. For example, amessage may be displayed on the display 90 or an audible tone or alarmmay sound when the error becomes too large. In one aspect, the systemmay automatically retract the guide instrument 4, sheath instrument 6,and working instrument 30 when the upper error limit is reached orsurpassed. This procedure would forcibly require the physician tore-baseline. Of course, as illustrated in FIG. 36, the prompt orsuggestion made to the physician may be advisory and the physician maychoose to ignore or disregard the suggestion made by the system andcontinue with the manipulation of the working instrument 30, guideinstrument 4 and/or sheath 6 instrument.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. The invention, therefore, should not belimited, except to the following claims, and their equivalents.

1. A robotic catheter manipulator comprising: a robotically operatedguide catheter including proximal and distal ends and a lumen extendingthere through; a flexible bellows having a first end and a second end,the first end being secured to the proximal end of the guide catheter; aseal secured to the second end of the flexible bellows, the sealconfigured to receive a working catheter; a ditherer operativelyconnected to the seal for dithering the working catheter relative to theguide catheter when placed therein; and at least one force sensor formeasuring the force applied to the working catheter by the ditherer. 2.The robotic catheter manipulator of claim 1, further comprising arobotically operated sheath concentrically arranged about at least aportion of the robotically operated guide catheter.
 3. The roboticcatheter manipulator of claim 1, wherein the seal comprises a Touhyseal.
 4. The robotic catheter manipulator of claim 1, wherein the atleast one force sensor comprises two force sensors.
 5. The roboticcatheter manipulator of claim 4, wherein the ditherer includes areciprocating carriage containing a pivoting load bearing member, thetwo force sensors being disposed on the carriage at opposing sides ofthe load bearing member.
 6. The robotic catheter manipulator of claim 1,wherein the two force sensors comprise compression force sensors.
 7. Therobotic catheter manipulator of claim 1, further comprising a computerconfigured for calculating an estimated force experienced by a distalend of the working catheter based at least in part on the obtained forcemeasurement for at least one dither cycle.
 8. The robotic cathetermanipulator of claim 7, further comprising a monitor for displaying theestimated force.
 9. The robotic catheter manipulator of claim 5, furthercomprising a clamp on the load bearing member, the clamp beingconfigured to secure the seal.
 10. The robotic catheter manipulator ofclaim 1, further comprising a clamp for securing a handle of the workingcatheter.
 11. The robotic catheter manipulator of claim 1, furthercomprising a removable drape for covering at least a portion of therobotically controlled guide catheter.
 12. The robotic cathetermanipulator of claim 1, the seal comprising an inlet port incommunication with the lumen of the guide catheter, the inlet port beingconfigured to receive a pressurized saline solution.
 13. The roboticcatheter manipulator of claim 1, wherein the robotically controlledguide catheter is connected to a guide catheter splayer.
 14. The roboticcatheter manipulator of claim 2, wherein the robotically controlledsheath is connected to a sheath splayer.
 15. The robotic cathetermanipulator of claim 5, wherein the carriage is coupled to areciprocating lever arm, the lever arm operatively connected at one endthereof to a bearing eccentrically mounted to a pulley, the pulley beingdriven by a cable.